A picture is worth a thousand words

Imagine this. You are a young person, aged 14. You’ve been living with a chronic, long-term condition for several years. You, along with your parents are sat with your doctor in the consultation room. They’ve asked whether you would like to take part in a clinical trial of a new medicine. You look to your parents, desperate for them to speak. You then look back at the doctor, and ask, ‘What will I have to do?’ They then hand you and your parents a 15 page ‘participant information sheet’, which details everything about the trial. They’ll call you in the next week to see if you are still interested. You walk out of the room and have no idea what to do.

Participant information sheets are a compulsory document which researchers must provide to everyone they invite to take part in a research study, to ensure people can make an informed decision about their participation in the study. These documents explain what taking part will involve and usually include details about:

why the research is being done, how long it will last, and the way in which the research is being conducted;

the possible risks and benefits;

what taking part will practically involve, for example, extra visits to a hospital or a researcher coming to interview someone at home;

what is being tested, or what topics an interview will cover;

how the researchers will keep participants’ information confidential;

what compensation is available to people if they are harmed as a result of taking part in the research;

who to contact for further information;

how the results will be shared with others.

That’s quite a lot of information and so inevitably, these documents tend to be very long! Researchers should already be involving patients, carers and members of the public in writing these documents. If a study is aimed at young people, then they should also be involved in writing these documents, so that they can be easily understood.

Randomised controlled trials are the best way to determine the effectiveness and safety of healthcare interventions. However, there are very few healthcare trials involving children and adolescents, meaning that important clinical decisions are based on evidence extrapolated from trials involving adults. A key barrier to these trials is the high rates of young person (or parent) refusal to participate. It is possible that this could be reduced by improving the quality of information that young people and their families receive about trial participation. The printed participant information sheets which are currently used in most trials have been widely criticised for being too long, technical and lacking in visual appeal. Multimedia interventions involving text, audio, video and animations have the potential to better inform young people and their families about trials, potentially leading to their increased participation and engagement in clinical trials.

Intervention comes from the Latin intervenire, meaning “to come between, to interrupt.” Often, an intervention is intended to make things better, and in healthcare, this could be a new medicine, treatment, procedure or technique.

As part of the TRECA research study, I’ve been involved on the patient and parent advisory group since May 2016. It’s been a fantastic opportunity to work alongside other patients, parents, researchers and health professionals to address this really important piece of research, which could have an enormous impact on future research. The TRECA study will be completed in two phases, between 2016 and 2018.

Phase one is the development stage, where the research team will develop two multimedia interventions – one for parents, adolescents and older children, and another for younger children. These will be designed for use when young people are asked to consider taking part in a clinical trial. Both multimedia interventions will contain generic information about clinical trials, such as explaining randomisation and study withdrawal, and information specific to an individual trial, for example, its purpose, length and whether people will need additional hospital appointments.

Development of the multimedia interventions will be influenced by the views of young people with long term conditions, parents, carers, health professionals and researchers. The multimedia interventions will also be ‘user tested’ for their ability to inform young people and their families. This process will identify any parts of the multimedia intervention which are not understood by young people and parents, and therefore, will be improved by the research team before phase two of the research.

Phase two is the evaluation stage, where the multimedia interventions will be embedded in the recruitment phase of six clinical trials which are recruiting young people. TRECA researchers will then test the impact of the multimedia interventions on decision making by comparing rates of trial recruitment (whether young people decide to participate) and retention (whether they stay on it) between young people who receive the multimedia interventions alongside the currently printed participant information sheets, and those who just receive the printed participant information sheet.

The results of this study will hopefully enable the rollout of multimedia interventions across all clinical trials and healthcare research opportunities – not just for young people, but for adults too – making printed participation information sheets a thing of the past!

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Simon Stones, BSc (Hons), AMRSB, is a Biomedical Sciences graduate and a doctoral researcher in child and family health. He is a passionate activist and ambassador for young people living with invisible illnesses, inspired and empowered by his own journey with arthritis, fibromyalgia, and inflammatory bowel disease.